Description : Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Description : Global Competition Enforcement New Players, New Challenges Edited by Paulo Burnier da Silveira & William Evan Kovacic In a short span of years, the landscape of global competition has changed significantly. In particular, international cooperation in competition law enforcement has greatly strengthened the battle against abuse of dominance, cartels, anticompetitive mergers and related political corruption. This thoroughly researched book explains the current situation regarding joint investigations, identifies common problems and considers possible solutions and future developments. In addition to covering issues of competition policy, its authors look in detail at practice in both merger and conduct investigations in a variety of countries. The following aspects of the subject and more are examined in depth: the interface between antitrust and anti-corruption; the digital economy’s challenges to competition authorities; convergent aims and rules among different competition authorities; regional organizations with competition mandates; competition neutrality and state-owned enterprises; and leniency programmes. Although necessarily there is considerable information on major antitrust regimes like those of the United States and the European Union, chapters by local experts highlight lessons to be learned from the work of competition authorities in five continents including Argentina, Australia, Brazil, China, Colombia, India, Japan, Mauritius, Mexico, Peru and South Africa. The contributors include competition enforcers, regulators, academics, practitioners and leading commentators from a range of jurisdictions. Adding up to an authoritative analysis from the enforcer’s perspective, the studies presented in the book clarify the approaches and priorities of competition enforcement authorities – including those of major emerging economies – and provide expert guidance on dealing with transnational investigations. Antitrust lawyers, corporate counsel and interested academics as well as policymakers will benefit immeasurably from this book’s wealth of informative detail.
Description : Competition enforcement authorities use settlements as a tool to ensure compliance with antitrust law. Companies can make commitments to remedy breaches, ensuring that they avoid litigation and potential fines and reputational damage. The author of this highly original and innovative book shows that, rather than fines or arguing principles of competition law in litigation, antitrust settlements (namely U.S. consent decrees and EU commitment decisions) hold the key to globally effective enforcement, particularly in the digital and blockchain era. Antitrust law does not necessarily need to be abolished, but rather should be fully exploited as an economic regulation led by antitrust settlements. In supporting her thesis, the author examines such elements of competition enforcement as the following: drawbacks of allowing the courts to regulate markets; whether antitrust settlements sacrifice antitrust deterrence; how settlements rapidly and surgically regulate markets; comparative analysis between U.S. consent decrees and EU commitment decisions; economic analysis on the adoption of antitrust settlements in both the U.S. and EU markets from 2013 to 2018; fundamental role of antitrust settlements in regulating the current digital markets; and comprehensive description on how to use antitrust settlements to regulate the data industry. With its thorough guidance on U.S. consent decrees and EU commitment decisions from their functioning to their characteristics and procedure—and its extensive treatment of the main antitrust remedies available and used in enforcing of antitrust law in both the U.S. and EU—the book provides both an economic and a legal analysis of the functioning and the scope of antitrust settlements. It assesses the influence of decisions on companies’ behavior and agencies’ practice, using economic analysis to show the procompetitive or anticompetitive effects of remedies, with special attention to digital markets. Because markets have become so dynamic and unpredictable that is difficult to preserve efficiency, the author says, there is a little room for law—economic regulation is a better fit. This book is a springboard to further investigate how a simple antitrust enforcement tool, having turned competition law into an economic regulation policy, can drive our economy, leading both the antitrust and regulatory interventions in tackling today’s market challenges.
Description : Although competition law and intellectual property are often interwoven, until this book there has been little guidance on how they work together in practice. As the intersection between the two fields continues to grow worldwide, both in case law and in regulation, the book's markets-based approach, focusing on sectors such as pharmaceuticals, IT, telecoms, energy and agriculture in eleven of the world's most active jurisdictions, provides a much-needed in-depth understanding of how this interplay reveals itself among the different legal systems. Written by a range of authors including judges, regulators, academics, economists and practitioners in both fields, the book provides an international comparative perspective as well as detailed analysis of specific cases, policies and proposals for change. Among the issues and topics covered are the following: – free movement of goods and the protection of intellectual property rights; – standard essential patents & injunction in patent cases; – intellectual property rights between technological development and consumer protection; – geo-blocking; – online platforms and antitrust; – excessive prices. In this context, special attention is paid throughout to the increasing dialogue among Competition Authorities and between Judges and Competition Authorities around the world. As matchless remedy for the lack of uniformity heretofore, the book's investigation of the nexus between competition law and intellectual property in different sectors and in various countries takes a giant step towards a more-balanced approach and more-levelled regulation and practices. It will be warmly appreciated by policy makers, decision makers, regulators, practitioners and academics in both competition law and intellectual property fields
Description : For decades, the debate about the tension between IP and antitrust law has revolved around the question to what extent antitrust should accept that IP laws may bar competition in order to stimulate innovation. The rise of IP rights in recent years has highlighted the problem that IP may also impede innovation, if research for new technologies or the marketing of new products requires access to protected prior innovation. How this 'cumulative innovation' is actually accounted for under IP and antitrust laws in the EU and the US, and how it could alternatively be dealt with, are the central questions addressed in this unique study by lawyer and economist Thorsten Käseberg. Taking an integrated view of both IP and antitrust rules – in particular on refusals to deal based on IP – the book assesses policy levers under European and US patent, copyright and trade secrecy laws, such as the bar for and scope of protection as well as research exemptions, compulsory licensing regimes and misuse doctrines. It analyses what the allocation of tasks is and should be between these IP levers and antitrust rules, in particular the law on abuse of dominance (Article 102 TFEU) and monopolisation (Section 2 Sherman Act), while particular attention is paid to the essential facilities doctrine, including pricing methodologies for access to IP. Many recent decisions and judgments are put into a coherent analytical framework, such as IMS Health, AstraZeneca, GlaxoSmithKline (in the EU), Apple (France), Orange Book Standard (Germany), Trinko, Rambus, NYMEX, eBay (US), Microsoft and IBM/T3 (both EU and US). Further topics covered include: IP protection for software, interoperability information and databases; industry-specific tailoring of IP; antitrust innovation market analysis; and the WTO law on the IP/antitrust interface.
Description : This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Description : This publication examines how drug originator manufacturers manage to shield their products from competition. It characterizes the pharmaceutical industry in detail and analyzes actions that violate antitrust laws in the USA and/or the European Union. The publication examines, for example, pay-for-delay strategies, market foreclosure, resale price maintenance, but also mergers and acquisitions, while taking into account market specificities such as the unique research and development process. The study explains why drug prices sometimes remain at elevated levels even after the drug’s patent protection has expired. Knowing the characteristics of such anticompetitive strategies helps customers such as health insurance companies to develop effective counter-strategies.
Description : Rapid technological innovations have challenged the conventional application of antitrust and competition law across the globe. Acknowledging these challenges, this original work analyses the roles of innovation in competition law analysis and reflects on how competition and antitrust law can be refined and tailored to innovation.
Description : 'This volume contains many excellent chapters on some of the most cutting edge topics in competition law today. Among the contributions are assessments of new approaches to competition law analysis, analyses of central and controversial topics in the relationship between competition law and intellectual property, and explorations of new transnational developments in China and elsewhere. The chapters range from studies of specific cases to broad interpretations of major trends. I found many of them to be highly insightful and very useful.' – David J. Gerber, Chicago-Kent College of Law, US 'This fresh collection of essays by scholars from around the world lives up to its title: it stakes out more common ground for the competition law systems of nations. The chapters result from the fourth annual conference of the Academic Society for Competition Law (ASCOLA). The essays cover major issues that reverberate around the world today, including: How should we think about the economic foundations of competition law in view of new research on behavioral economics and consumer choice? What is the future of the treatment of resale price maintenance? What is the proper fit of intellectual property with competition law? And how do we promote competition law and policy across borders? The collection offers insight from law, economics, political science, business strategy, and history.' – Eleanor Fox, New York University, US In recent years, an impressive proliferation of competition laws has been seen around the world. Whilst this development may lead to greater diversity of approaches, economic arguments may promote convergence. The contributions to this book look at a number of most topical issues by asking whether the competition world is turning more towards convergence or diversity. These issues include, among others, the changing role of economics in times of economic crises and political change, the introduction of criminal sanctions, resale-price maintenance, unilateral conduct and the application of competition law to intellectual property and state-owned enterprises. More Common Ground for International Competition Law will appeal to academics, PhD students, and postgraduate students law and economics, members of competition agencies, legal practice and international business.